Catalog Number

5688320

Brand Name

LEADER

Version/Model Number

5688320

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DIT

Product Code Name

Thin layer chromatography, amphetamine

Public Device Record Key

ed3f1fbf-b518-4e03-9a17-5bff8c1aaea3

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 11, 2021

Package DI Number

50096295140571

Quantity per Package

6

Contains DI Package

00096295140576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE